Description

Norfloxacin & Tinidazole Film-Coated Tablets (400 mg / 600 mg)

Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, gastroenterological, and syndromic-management therapeutics. We provide ultra-high-purity, kinetically synchronized Norfloxacin & Tinidazole Film-Coated Tablets (400 mg / 600 mg), manufactured in WHO–GMP certified, high-precision multi-particulate oral solid dosage facilities. This “Gut-Targeted Dual-Spectrum Synergy” is a massive-volume, highly lucrative export to gastroenterology clinics, rural health NGOs, emergency departments, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted, first-line intervention for acute amoebic dysentery, mixed gastrointestinal infections, and complicated urinary tract infections.

Product Overview

This highly advanced Fixed-Dose Combination masterfully synchronizes a gut-concentrating fluoroquinolone with a premium, long-acting nitroimidazole, delivering a devastating, two-pronged attack that completely eradicates aerobic bacteria, anaerobic bacteria, and protozoal parasites simultaneously.

The “Syndromic Management & Gut-Concentrating” Specialist:

• Mechanism 1 (The Aerobic Gut Sweeper – Norfloxacin): Norfloxacin aggressively targets Gram-negative aerobic bacteria (like E. coli, Salmonella, Shigella, and Campylobacter) responsible for severe food poisoning and traveler’s diarrhea. It physically enters the bacterial cell and binds to DNA gyrase. By locking this enzyme, Norfloxacin forcefully breaks the bacterial DNA strands, causing rapid cell death. Crucially, Norfloxacin achieves massive, lethal concentrations specifically within the intestinal lumen and the urinary tract, making it highly targeted.
• Mechanism 2 (The Anaerobic/Protozoal Shredder – Tinidazole): While Norfloxacin kills the oxygen-breathing pathogens, Tinidazole hunts the tissue-invasive pathogens that thrive without oxygen (like Giardia lamblia and Entamoeba histolytica). Once inside an anaerobic cell, Tinidazole is chemically reduced into highly toxic, reactive free radicals that violently shred the organism’s DNA from the inside out, curing severe amoebiasis.
• The “Blind Therapy” Advantage: In acute, life-threatening diarrheal diseases in resource-limited settings, waiting days for stool culture laboratory results is not clinically viable. This synergistic combination provides complete, overlapping “blind” coverage, guaranteeing that whatever pathogen is driving the severe diarrhea is eradicated quickly, making it a massive staple in global health and NGO tenders.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Intensive Taste-Masking & High-Shear Granulation: Fluoroquinolones and Nitroimidazoles are two of the most bitter chemical classes in pharmacology. If the tablet dissolves even slightly in the mouth, the patient will immediately vomit it back up. Our facilities utilize advanced high-shear wet granulation to safely blend the APIs, followed immediately by a heavy-gauge, multi-layer Hypromellose (HPMC) film-coating process. This locks the massive 1000 mg payload inside a perfectly smooth, tasteless shell, ensuring complete therapeutic delivery into the stomach.

Therapeutic Indications (Human Use)

Indicated for the targeted, broad-spectrum eradication of severe mixed gastrointestinal and pelvic infections:

• Acute Diarrhea & Amoebic Dysentery: Syndromic treatment of severe, complicated gastroenteritis of mixed bacterial and amoebic/protozoal origin.
• Pelvic Inflammatory Disease (PID): Treatment of complex gynecological infections.
• Complicated Urinary Tract Infections (UTIs): Management of severe UTIs where mixed aerobic and anaerobic flora is suspected.
• Surgical Prophylaxis: Prevention of post-operative infections following gastrointestinal or gynecological surgery.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

• Standard Adult Dosing: One tablet taken orally twice daily (every 12 hours) for 5 to 10 days, depending on the severity of the infection.
• Administration (THE MEALTIME RULE): To drastically reduce the risk of severe gastric irritation, the tablets MUST be taken immediately after meals with a full glass of water.
• Dairy & Antacid Warning: Norfloxacin aggressively binds to calcium, magnesium, and iron. Tablets must not be taken within 2 hours of dairy products, antacids, or iron supplements, as this will completely block the antibiotic’s absorption into the blood.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Tendon Rupture & Neuropathy): Fluoroquinolones (Norfloxacin) are associated with disabling and potentially irreversible serious adverse reactions, including spontaneous tendon rupture (especially the Achilles tendon), peripheral neuropathy, and severe central nervous system effects. Discontinue immediately at the first sign of tendon pain.
• Alcohol Interaction (Disulfiram-Like Reaction): Patients must be heavily warned to avoid all alcohol consumption during therapy and for at least 3 days after the last dose to prevent violent nausea, vomiting, flushing, and tachycardia caused by the Tinidazole component.
• Myasthenia Gravis Exacerbation: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with Myasthenia Gravis.
• Pregnancy & Pediatrics: Strictly contraindicated in pregnant women, nursing mothers, and children/adolescents under 18 years of age due to severe risks of cartilage damage in developing weight-bearing joints.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anti-Infective and FDC Formulations. Whether you are looking for a reliable Government Tender Supplier for dysentery outbreak control in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.